Cleared Traditional

CONTOUR NEXT EZ BLOOD GLUCOSE METER

K130265 · Bayer Healthcare, LLC · Chemistry
Jun 2014
Decision
504d
Days
Class 2
Risk

About This 510(k) Submission

K130265 is an FDA 510(k) clearance for the CONTOUR NEXT EZ BLOOD GLUCOSE METER, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Bayer Healthcare, LLC (Mishawaka, US). The FDA issued a Cleared decision on June 23, 2014, 504 days after receiving the submission on February 4, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K130265 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2013
Decision Date June 23, 2014
Days to Decision 504 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NBW — System, Test, Blood Glucose, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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